Phar-East 2018 Programme Agenda

 

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Singapore, 28 February 2018 - 2 March 2018

Schedule

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Feb 2809:00
Conference pass
Feb 2809:10
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Defining innovation from an investor perspective

Biotech workshop
Feb 2809:40
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Perspective of a life sciences VC: What are investors looking for in a biotech start-up

Biotech workshop
Feb 2811:00
Conference pass

Building an entrepreneurial management team

Biotech workshop
Feb 2811:30
Conference pass

Effective digital strategy in biotech start-up business

Biotech workshop
Feb 2812:00
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Breakout group discussion 1

Biotech workshop
Attendees to break into group of 3-4 each discussing on a specific topic for 25 minutes. Each group will be given 5 minutes to present on 3 key learning from the brainstorm session.

Topic 1: Beyond creativity: Systematic approach to build a successful business
Hardy Chan, Chairman & President of Allianz Pharmascience, Co-founder and senior advisor of ScinoPharm, Taiwan

Topic 2: Innovation process in product development and company building
Shwen Gwee, Head of Digital Strategy, Global Clinical Operations, Biogen, USA

Topic 3: Essential ingredients and options in funding the business
Hui Hsing Ma, Senior Deal Advisor, SEA, TVM Capital Healthcare, Singapore

Topic 4: Building the right partnership to accelerate, de-risk and sustain business relationship
Bien Kiat Tan, Founder, Titan Capital, Singapore
Feb 2814:15
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Developing your business plan

Biotech workshop
Carrie Hillyard, Chairman, FitGenesAustralia
Feb 2814:45
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Capitalising your venture (Topic to be confirmed)

Biotech workshop
Himanshu Brahmbhatt, Joint CEO & Director, EnGeneIC Pty LtdAustralia
Feb 2815:45
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Overview of biotech start up environment in India, opportunities and challenges

Biotech workshop
Bio entrepreneurship is not for the faint hearted. It requires huge investment, effort and long return period to see slight tangible result from massive pour of funds into R&D and operations. In this session, we present on the overview of healthcare start up environment in India, its challenges and innovation & collaboration required to foster the ecosystem. The session will also cover the common pitfall in start-ups, and practical advices on making your business more investable from an investor perspective
 
Feb 2816:15
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Breakout group discussion 2

Biotech workshop
Topic 5: Business Plan and Pitch in the Fundraising Process
Carrie Hillyard, Chairman, Fitgenes, Australia
Topic 6: Pre-seed/Seed Funding Pitch
Himanshu Brahmbhatt, Joint-CEO & Director, EnGeneIC, Cancer Therapeutics, Australia
Topic 7: Qualification of technology as a basis of business start up
Abha Inamdar, Assistant Vice President, Innovations Fund, Private Equity, Tata Capital, India
Moderator: Carrie Hillyard, Chairman, FitGenesAustralia
Moderator: Himanshu Brahmbhatt, Joint CEO & Director, EnGeneIC Pty LtdAustralia

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Mar 108:50
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Mar 109:00
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Venture capital funding for the biotech industry

Keynotes
It takes millions of dollars to transform an innovative idea to a commercially viable pharma product. Especially in developing countries where the government has other more important healthcare priorities, the role of the VC becomes even more crucial and necessary for early stage biotech company and its success. Find out how venture capitalists can tap on knowledge learnt from more established biotech ecosystem and apply these lessons in Asia. 
Mar 109:20
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Fostering biotech and bio-entrepreneurship in Southeast Asia (SEA): How do we build the next biotech unicorn in SEA?

Keynotes
Southeast Asia is a geographically diverse region diverse lifestyles and traditions. The majority of SEA countries are still in developing stages and R&D intensive industries are not a priority compared to industries that rapidly close the income gap between the rich and the needy. Nonetheless, we are beginning to see a thriving biotech landscape offering innovative solutions. What needs to be done to help these promising companies fully realise their potential? How can the region come together to support the biotech industry, and build a biotech unicorn? 
Mar 109:40
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The Macro View: What will it take for Asia’s biotech industry to really flourish?

Keynotes
Everyone knows it is too generic to classify all Asian countries in a single category. With the exception of China and India, the remaining part of Asia is complicated, fragmented and diversified. With growing GDPs and middle class populations, the potential of Asia’s biotech industry is undeniable in the eye of global leaders. The main question is, how can government and related stakeholders assist the biotech industry to flourish to provide more affordable, personalised medicine for its populations? How do countries move away from a “me-too” to “me-first” mentality, especially when it comes to pharma R&D?
 
Mar 110:55
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SOUTH ASIA

Partnering & Licensing
Join us at this interactive roundtable session for an informal, one hour discussion with local pharma companies interested licensing their products. Ideal for pharma companies looking for local partners and distributors, and for distributors looking for new business opportunities.
INDIA
  • Dinesh Kundu, Biologics Strategy and Project Manager, Intas Pharmaceutical, India
  • Kaustubh Berde, Vice President, Emerging Markets, Wockhardt, Indi
  • Sujay Singh, President & CEO, Imgenex India Pvt. Ltd, India
More attendees to be announced onsite
Mar 110:55
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Mar 110:55
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Chair's Opening Remarks

Market Access
Lalit Baregama, General Manager of Global Business Development, Cadila Pharmaceutical Ltd.India
Mar 110:55
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Chair's Opening Remarks

Biotech Innovation
Carrie Hillyard, Chairman, FitGenesAustralia
Mar 111:00
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Role of manufacturers in clearing vaccines misconception

Vaccines
  •     Investigating the origin of misconception regarding vaccination
  •     Existing educational and advertising efforts and future actions required to clear such misconception
  •     Religion vs science: Is there a violation in religion to get vaccinated?
  •     Updates on halal vaccines and plans forward
Mar 111:00
Conference pass

mAb Industry in China: Biosimilars vs. Innovative Biologics

Biosimilars
Following patent cliffs for Erbitux, Rituxan, Sandosta_n and several big blockbusters, Herceptin, Avastin are now among the next biosimilar targets. This is creating huge potential for biosimilars, prompting innovators to shift their focus to target more emerging markets which remain untapped for many companies. In this presentation, Joe will be sharing with you his vision of the biosimilars market with a focus on China. He will also discuss key considerations for mAb and biologics therapeutic development, providing a broad overview of challenges and opportunities presenting in the market.
 
1.        Landscape changes of mAb therapeutics
2.        New targets and process/manufacturing innovation
3.        Key consideration of mAb industry in China
4.        Case study: Development strategies of PD-1 mAb as anti-tumor therapeutics in China for global market
Mar 111:00
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Cancer precision medicine: From screening to drug selection and development

Immunotherapy
  • Personalised, affordable and high efficacy are the ideal criteria of a medicine. But the big question is how do we actually move towards providing highly personalised medicine to patients in need?
  • Investigate the pathway to the future of medicine, from drug discovery, development to reaching out to the patients.
Mar 111:00
Conference pass

Digital trends impacting clinical trials

Pharma 4.0
  • An overview on how data can transform pharma trials, from recruiting patients to real time drug performance evaluation
  • Using digital tools to optimise site selection, identification and engagement
  • Enhancing patient recruitment and compliance in trials conduction
Mar 111:00
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Building the right ecosystem to support the new era of Indonesia biopharma industry

Market Access
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  •     Overview of innovation and investment made to promote pharma industry in Indonesia 
  •     Case study: Joint venture with Genexine to produce biobetter drugs in Indonesia.
  •     Insights learnt from drug development, clinical trials and manufacturing biologics in home grown facilities to support local, ASEAN and greater Asia population 
Mar 111:00
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Mar 111:10
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Biotech Showcase

Biotech Innovation
Mar 111:20
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Building affordable and sustainable vaccines framework for neglected diseases in Asia

Vaccines
  •     Quick overview of International Vaccine Institute (IVI) and its achievement so far
  •     Building an effective tech transfer model for quality local accessibility 
  •     Updates on IVI latest projects and collaboration opportunities
Mar 111:20
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Challenges & strategies for biosimilar business in emerging markets

Biosimilars
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  •     Overview of current situation  and Challenges  in Emerging Market;
  •     Strategies in exploring different territories in Asia
  •     Overview of New guideline for biosimilar in China  
Mar 111:20
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Awakening the immune system against cancer - Moving into the clinic

Immunotherapy
Is cancer immunotherapy the beginning of the end of cancer? Discover cases where immunotherapy can be used to treat complicated cancer cases, including leukaemia, breast cancer and more.
 
Mar 111:20
Conference pass

Disrupting Clinical Trials as a Care Option

Pharma 4.0
  •     The millennials are behaving differently, they are listening on different channels, they are demanding more, and they are willing to accept much less burden than before.
  •     Advancing Clinical Trials as a Care Option will become increasingly difficult through Primary Care Physicians – the Answer – a Connected and Data Driven consumer approach to Clinical Trials
  •     We believe that in order for life-science & healthcare companies to engage Subjects in a mobile world, they must be 100% Consumer Centric.
Mar 111:20
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Case study: Strategic partnership for effective pharmaceutical development and manufacturing

Market Access
Lalit Baregama, General Manager of Global Business Development, Cadila Pharmaceutical Ltd.India
Mar 111:20
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Mar 111:30
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Case study: Practical steps to prepare for product launch in APAC and Greater China

Market Access
Anushree Agarwal, Senior Manager - Launch Readiness & Excellence For Emerging Markets, TakedaSingapore
Mar 111:30
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Biotech Showcase

Biotech Innovation
Mar 111:40
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Vaccination program in Vietnam and its health impact

Vaccines
  •     Sharing of current and upcoming vaccination program in Vietnam
  •     Measuring success of current initiatives and strategies to improve next step in nationwide vaccination
  •     Preparing for epidemic and infectious diseases: Key steps and considerations
Mar 111:40
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Cost vs quality: What’s the best strategies for Asia biosimilars market?

Biosimilars
  • Exploring strategies in addressing differences in biosimilar regulation
  • Case study: Regulated vs unregulated biosimilars market in Asia
  • Overcoming challenges in tech know-how and different approaches and understanding of concepts by regulatory agencies
Mar 111:40
Conference pass

Global pipeline development to serve Asia population

Immunotherapy
  •     APAC strategy to develop promising pipeline for Asia-prevalent indications 
  •     Key pipelines sharing and thoughts on potential development collaboration in the region
  •     Shifting from cure to predictive and preventive studies: How are we doing so far?
  •     Moving beyond science & R&D: What are we lacking to advance towards creating personalised medicine in Asia
Mar 111:40
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Genome data mining and analysis for new drug discovery

Pharma 4.0
  •     Identifying key gaps between current clinical trial methods with personalised treatment  
  •     Exploring key methods in genomics data mining and matching with patients to identify personalised treatment 
  •     Case study from Samsung Genomic Institute on the pathway towards personalised treatment
Mar 111:40
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Panel discussion: To partner or to launch? Strategies for exploring Asia’s emerging markets

Market Access
  • Analysing commercial opportunities and in-country competition to formulate most the optimal access strategy
  • How do innovators compete with biosimilars to keep their market share of expiring biologics products? Is it about more than just price?
  • Case study
Moderator: Lalit Baregama, General Manager of Global Business Development, Cadila Pharmaceutical Ltd.India
Anushree Agarwal, Senior Manager - Launch Readiness & Excellence For Emerging Markets, TakedaSingapore
Mar 111:40
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Mar 112:00
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Roundtable Discussion Session

Keynotes
Now's your chance to get really interactive. Simply pick a table and join the debate. 
Mar 112:00
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Case study: Development of inactivated Zika Vaccine from vero cell

Vaccines
  •     Overcoming challenges caused by the limited knowledge on the zika virus structure, virulent factors, and replication mechanism in its vaccine development.
  •     Updates on Changsheng Life Sciences effort in developing Zika vaccines
  •     Strategies in evaluation of vaccine efficacy and future plans moving forward
Mar 112:01
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Table 1: Innovative platforms for small molecules and gene therapy drug development

Keynotes
Mar 112:01
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Table 2: Avoiding delays in clinical manufacturing of drug product

Keynotes
Manufacturing issues were the primary reason given for non-approvals in many of the response letters issued by the FDA in 2016. These manufacturing issues not only delay drug development, but also complicate the relationship between drug firms and their contract manufacturers. We will discuss the common issues, including planning, risk management, selection of primary packaging & materials, contract documents, and guidelines for choosing the right partner that can offer the quality necessary for successful clinical manufacturing. A trustworthy CDMO supports you with realistic project timelines and a framework of high product quality, while you focus on your core competencies of discovery and clinical development.
Mar 112:01
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Table 3: Launching new biologics production line

Keynotes
Mar 112:01
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Table 4: Commercial strategies for digital health in Asia

Keynotes
Mar 112:01
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Table 5: Why don’t we have an ICI in breast cancer – yet?

Keynotes
Mar 112:01
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Table 6: Working on a start-up setting, from clinical development to commercialisation

Keynotes
Mar 112:01
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Table 7: AI& Big data in drug discovery

Keynotes
Mar 112:01
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Table 8: Preparation steps to brace healthcare & pharma digital transformation

Keynotes
Mar 112:01
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Table 9: Patient centricity in oncology studies

Keynotes
Mar 112:02
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Table 10: Bringing it together: Roles of Patient, Pharma, Hospital and Government in Drug Development

Keynotes
Mar 114:10
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NORTH EAST ASIA

Partnering & Licensing
Join us at this interactive roundtable session for an informal, one hour discussion with local pharma companies interested licensing their products. Ideal for pharma companies looking for local partners and distributors, and for distributors looking for new business opportunities.
 
CHINA
  • Forrest Hu, General Manager, International Business, 3SBio, China
  • Ke Wu, CEO, BravoVax, China
  • H.Fai Poon, Chief Scientific Officer, Zhejiang Hisun Pharmaceuticals, China
  • Tim Collard, CEO, Pacific Gene Tech, China
  • Joe Zhou, CEO, Genor Biopharma, China
  • John Zeng, Executive Vice President, Shanghai Zerun Biotech, China
  • Tony Liu, CEO & CFO, Cellular Biomedicine, China
  • Lei Xiao, CSO and Chairman, Innovative Cellular Therapeutics (Formerly Sidansai Pharma), China
  • Gloria Wang, Executive Director, Clinical Development Just Biotherapeutics, China
  • Shuyuan Yao, Vice President, Operations, JW Therapeutics, China
JAPAN
AMED, Japan
Kenji Kakuta, President & CEO, iHeart Japan Corporation, Japan
 
KOREA
Antonio Lee, CEO & Managing Director, Medipost America, Global Head, Business Development, Medipost, South Korea
Jin-San Yoo, CEO, PharmAbcine, South Korea
Woong-Yang Park, Director, Samsung Genomic Institute, South Korea
Korean BioVenture Startup

More attendees to be announced onsite

 
Mar 114:10
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Mar 114:10
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Mar 114:20
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Addressing the complexity in low cost, high volume vaccines manufacturing

Vaccines
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  •     Exploring strategies to meet regulatory requirement in low cost, high volume quality manufacturing
  •     Cost vs innovation: How do we continuously innovate within the low profit margin business
  •     Case study and analysis
Mar 114:20
Conference pass

Choosing the right country for biosimilars trial

Biosimilars
This presentation describes how the access to patient centric real world data helps to provides insights to enable evidenced based, predictive and proactive approach to the management of biosimilars trials. It will also describes the importance of past experience and new insights in trial design, planning and execution to improve the success rate to both sponsor and CRO to bring new biosimilars to market on time to patients in need.
Kate Lawrey, Associate Director, Operations Lead – Asia Next Generation Clinical Development, IQVIASingapore
Mar 114:20
Conference pass

Anti-viral immunotherapy: A case study

Immunotherapy
Chronic viral infection predisposes a person to the development of cancer. The integrated viral genes in infected cells can be expressed to create viral peptides and presented onto the cell surface. Using our proprietary TCR platform, patient’s T cells can be engineered with high-avidity antiviral TCRs which recognize the tumor-specific viral peptides, leading to the release of cytolytic molecules and the lysis of cancer cells.
Mar 114:20
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Big data & AI in digital rare disease patient recruitment

Pharma 4.0
  • Using supercomputer and AI in matching patients to trials
  • Aligning your strategy & planning with R&D objectives
  • Evaluating and improvising planned digital clinical trial strategy
Mar 114:20
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Value in healthcare: A payer’s perspective

Market Access
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  •     Overview of current healthcare and reimbursement system in Asia
  •     From a payer’s perspective, what needs to be done to tackle pricing trends, from reimbursed to out of pocket markets
  •     Case studies
Mar 114:20
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Investor Insights

Biotech Innovation
Yichung Law, Head of Biomedical Sciences, Singapore Economic Development BoardSingapore
Mar 114:30
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Biotech Showcase

Biotech Innovation
Mar 114:40
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Challenges, innovations and opportunities in Chinese state owned vaccines company: A case study on Chengda Biotech

Vaccines
  •     Challenges in operating state owned vaccines company in China
  •     Key strategies forward
  •     Partnering opportunities available 
Mar 114:40
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India’s Biosimilar clinical trials landscape: What do you need to know?

Biosimilars
Regulation was previously a big issue in India but the country is making a comeback as a biosimilars trial destination. Join this session to learn more about the latest regulations and key requirements for conducting biosimilar trials in India. Topics include quality compliance in running biosimilar trials in India.
Mar 114:40
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Dendritic cell vaccines in Asia: The first CDSCO approved Indian dendritic cell cancer immunotherapy

Immunotherapy
Details to be announced
Mar 114:40
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AI in real time monitoring to improve survival rate of preventable diseases

Pharma 4.0
Mar 114:40
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Promoting access to healthcare in developing countries

Market Access
  •     Exploring the win-win pricing structure where payers, pharma and patients will be best benefitted
  •     Latest update in country, from pharma to biologics and orphan products
  •     Case studies
Mar 114:40
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Biotech Showcase

Biotech Innovation
Mar 114:50
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Mar 115:00
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Effective technology transfer for sustainable, quality production and accessibility

Vaccines
  • Ensuring equity between partners and equitable TT meets both parties’ expectations
  • Freedom to operate once the recipient receive the TT to ensure production sustainability
  • Building suitable regulatory capacity for quality monitoring and approval
John Zeng, Executive Vice President, Shanghai Zerun Biotechnology Co LtdChina
Mar 115:00
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Moving from generic antibody supplier to biosimilars developers: Key insights learnt from development to biosimilars productions

Biosimilars
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  •     Sharing of company background and insights learnt moving from antibodies supplier to biosimilars developer 
  •     Discussing strategies to maintain product quality in upscaling biosimilars
  •     Exploring key assays techniques and development for biosimilars testing
Mar 115:00
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Nanocell platform for the targeted cyto-immunotherapy in cancer

Immunotherapy
Himanshu Brahmbhatt, Joint CEO & Director, EnGeneIC Pty LtdAustralia
Mar 115:00
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Digital tools to achieve patient centricity

Pharma 4.0
Patient centricity should not be just another buzz word, nor should it be a nebulous concept. Quite simply, when we consider the motivators and deterrents of today’s well connected and digital patients, this becomes the first step in developing and adopting a patient-centric approach. As such, let’s examine how one’s “digital breadcrumb” can be used to more effectively to identify and engage with patients.
Mar 115:00
Conference pass

Impact of India’s latest pharmaceutical policy on drug development, production, pricing and reimbursement

Market Access
  •     Overview of latest regulatory landscape and how it affects domestic and international stakeholders
  •     Exploring opportunities and hurdles presented by the new policy
  •     Focusing on pricing & reimbursement: What does local and international pharma companies need to know to prepare for this change? 
Mar 115:00
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Biotech Showcase- HSP105 peptide vaccine

Biotech Innovation
We completed Phase 1 by a investigator-initiated clinical trial of peptide vaccine intradermal injection for advanced colorectal cancer and esophageal cancer, and have confirmed safety and CTL inducing ability. In the future, we hope to develop combination therapy with anti-PD-1 / PD-L1 antibody or development of intratumoral local injection therapy of peptide vaccine by company-initiated clinical trial.
Mar 115:10
Conference pass

Biotech Showcase- Development of rapid quantitative ex vivo therapeutic sensitivity analysis system for phenomics-based personalized medicine of hepatic and pancreatic cancers

Biotech Innovation
In order to develop a rapid therapeutic drug sensitivity analysis system enabling phenomics personalized medicine in clinical pancreatic cancer, the maximum quantitative therapeutic drug susceptibility analysis is performed regardless of the clinical pancreatic cancer sample situation. We have established a protocol to realize and acquired POC for practical application of ex vivo diagnostics for susceptibility to cancer therapeutic agents. 
Mar 115:20
Conference pass

The next big immune checkpoint: LAG-3

Immunotherapy
  •     The potential of LAG-3 in immune oncology and autoimmune diseases
  •     Combination therapy as a key therapeutic strategy in oncology
  •     Collaborations as a path to success in global drug development
Mar 115:55
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Chair’s opening remarks

Biosimilars
Mar 116:00
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SOUTH EAST ASIA

Partnering & Licensing

Join us at this interactive roundtable session for an informal, one hour discussion with local pharma companies interested licensing their products. Ideal for pharma companies looking for local partners and distributors, and for distributors looking for new business opportunities.
 
 
MALAYSIA & SINGAPORE
Tabassum Khan, Chairman, AJ Pharma, Malaysia
 
INDONESIA
Yuliana Indriati, President Director, PT Kalbe Genexine Biologics, Indonesia
 
THAILAND & VIETNAM
Wannarak Siraarparsate, Business Manager, Siam Bioscience, Thailand
 
Do Tuan Dat, General Director, Vaccine and Biological Production, Vabiotech, Vietnam
 
PHILIPPINES
Francis Wade Gomez, President and CEO, New Marketlink Pharmaceutical Corporation

More attendees to be announced onsite 
 
Mar 116:00
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Have we made enough progress in overcoming the unique challenges in conducting vaccine clinical trials in Asia?

Vaccines
    has been global recognition and discussion of the challenges associated with conducting vaccine trials in Asia but what has really changed?
  •     Overview of Challenges
  •     Possible Solutions:  What is being done by the Vaccine community including regulators, private/public partnerships, and NGOs
  •     Recent Examples / Case Study 
  •     Discussion:  Has there been enough progress?
Mar 116:00
Conference pass

Manufacturing strategies for Biosimilar: A case of continuous capture

Biosimilars
  • A case study of continuous capture process development
  • Key strategies in moving from batch to a continuous process
  • Integrating continuous cell culture and purification
Mar 116:00
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Building the framework of combination immuno-oncology (I-O)

Immunotherapy
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  •     Overview of current progress, lessons learnt and future prospect of combination I-O
  •     Investigating several combination of checkpoint inhibitors for more effective treatment
  •     Rational vs non rational combinations between checkpoint inhibitors and chemo/radio therapies, which works best?
Mar 116:00
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The Internet of Medical Things (IoMT): Deep technology in patient monitoring, electronic disease surveillance and beyond

Pharma 4.0
  • Generating and collecting electronic data and passive records from internet, mobile phones etc.
  • Designing participatory platforms and interactive digital infrastructure to allow better data collection
  • Combining e-health record (EHR), traditional and non-traditional digital data in disease surveillance, prediction and modelling
Mar 116:00
Conference pass

RWE Generation: The current realities and capabilities required in Medical Affairs

Market Access
  • Identifying challenges and opportunities using Real world evidence in reimbursement propositions
  • Cross-country analysis in better planning for HEOR execution
  • Setting digital platforms to connect patients to cloud for more accurate information gathering
Santosh Jha, Director of Medical Regulatory, TakedaIndia
Mar 116:00
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Investor Insights

Biotech Innovation
Ahmad Redzuan Sidek, Chief Investment Officer, ABio Sdn BhdMalaysia
Mar 116:10
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Mar 116:20
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Vaccine-induced immune correlates of protection

Vaccines
Measurement of pathogen-specific antibody levels have been used as indicators for immune correlates of protection for many of the licensed human vaccines. For many of these marketed vaccines, other yet to be defined immune correlates in additional to protective antibodies are expected to play their key roles as well. Absolute correlates of protective immunity are hard to establish, yet they are essential to guide the development of safe and efficacious vaccines for the unmet medical needs. This can only be gained through better understanding of host-pathogen interaction to be coupled with the application of immunomics and system vaccinology to profile vaccine-induced effector, reactogenic and memory immune responses that can be recalled upon exposure to naturally occurring microbes.
Mar 116:20
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Fully continuous biosimilar manufacturing framework: A case study

Biosimilars
  • Strategies in establishing a fully continuous biosimilar framework
  • Overcoming challenges connecting upstream and downstream sections in building continuous processing system
  • Case study
Mar 116:20
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Using genetic information to predict the effectiveness of combination immunotherapy

Immunotherapy
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  •     Using molecular analytics in creating effective combinations
  •     Disease modelling and prediction with big data and analytics
  •     Case study sharing
Mar 116:20
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Better decision making with big data analytics

Pharma 4.0
  • Making sense of huge data volumes when using data analytics
  • Building real-time analysis capabilities for useful information collected from variable sources
  • Using big data in production lines to increase maintenance efficiency, improve availability and optimise maintenance costs
Mar 116:20
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HTA in Taiwan: An update

Market Access
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  •     Introduction of ahealthcare framework in Taiwan, including the role of CDE and National Health Insurance (NHI) in reimbursement decision
  •     Understanding the role of HTA in Taiwan reimbursement evaluation process
  •     Best practices to ensure neutrality in evaluation process, including roles of drug providers and patients in evaluation processes  
Mar 116:20
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Mar 116:30
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Biotech Showcase- Highly immunodeficient mouse optimized for bioimaging

Biotech Innovation
A hairless highly immunodeficient mouse suitable for in vivo bioimaging and evaluation of novel therapeutic reagents for cancer and infection. 
Specifically disclosed is an immunodeficient mouse which has the following properties (a)-(d). (a) The mouse lacks T cells and B cells. (b) The NK activity is lost in the mouse. (c) The mouse is hairless. (d) Human normal and malignant cells are transplantable.
Mar 116:40
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Targeted nanoparticle based vaccine & chemo immunotherapy drug development

Vaccines
Mar 116:40
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What’s next in greener, more efficient biomanufacturing?

Biosimilars
After years of discussion, the industry is moving from traditional stainless steel based production to single use, continuous processing. In this exciting time, what is the next innovation which we can expect to create greener, more efficient methods for biologics production? 
Mar 116:40
Conference pass

Expansions of trials and combination of Tanibirumab + anti-PD1 antibody for refractory cancer patients

Immunotherapy
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  •     Insights learnt from Tanibirumab recurrent GBM phase IIa open labelled three arms multi-centre trial in Australia
  •     Expansions of trails for combination of Tanibirumab + anti-PD1 antibody for refractory tumours 
Mar 116:40
Conference pass

Multichannel transformation and digital marketing strategies in Asia (Topic to be finalised)

Pharma 4.0
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  •     Building digital channels to better engage patients
  •     Using deep technology to optimise life cycle management
  •     Case study
Mar 116:40
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Technology assessment for new oncology drug

Market Access
    evelopment of targeted therapies and personalised cancer drugs offers opportunities, but also increases the complexity of the assessment. In this session, we will examine :
  •     Strategies for the assessment of new treatments, including possible join assessment
  •     Best practice for translating trial efficacy into effective clinical practice
Mar 116:40
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Biotech Showcase

Biotech Innovation
Mar 116:50
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Create your personal agenda –check the favourite icon

Mar 209:10
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Shifting paradigm of the advanced therapy landscape in Asia

Keynotes
Recently raised to fame as the new miracle method to treat even the most stubborn cancer cases, CAR-T trials have proven to save patients who have failed all known treatment. From a pharma perspective, what methods can they adopt to produce these highly personalised, customised treatments at scale? Upon approval for commercial deployment, what else needs to be done to help patients afford the sky high cost of immunotherapy? Join this thought provoking presentation to hear from Tony Liu, CEO of CBMG and former senior executive of Alibaba and Microsoft to learn how this influential biopharma company take steps to prepare for the next miracle drug in making. 
Tony Liu, CEO& CFO, Cellular Biomedicine Group, IncChina
Mar 209:30
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Innovation beyond limit: How do we conquer incurable diseases and create new history

Keynotes
Advancement in research helps to push the limitation of treatment paradigm to attempt curing currently incurable diseases. Innovative therapeutic solutions however is often not sufficient without a strong team to help with commercialisation. In this presentation, Antonio will share about the overall landscape in Asia stem cell therapy, challenges in current landscape and opportunities ahead to achieve commercial excellence.  
Mar 209:50
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Educated guesses, lofty aspirations, hard realities

Keynotes
Ideas are free and to be able to catch one by the wings and bring it back to ground is a wonderful feeling indeed. For doctors, the next step is to bring this good idea into the wards for the patient’s benefit. The transition of bench research to bedside application seems very straightforward at first glance, but it is not until the first steps are taken that one realises the numerous hurdles that have to be surmounted in order to achieve this. In the best interests of the patient, this translational sequence is prescriptive and tedious, and yet it pays no heed to other essentials crucial for the translational effort to be truly successful. This presentation also shares the journey of CellResearch Corporation which 13 years to see the light at the end of the tunnel.
Mar 210:50
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Mar 210:50
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Chair's Opening Remarks

Cell & Gene Therapy
Mar 211:00
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Multi regional clinical trial (MRCT) harmonisation: An overview

Regulatory Affairs
This one hour session includes an overview presentation on MRCT in Asia, with quick 10-minute updates from Japan, Taiwan, Malaysia, Singapore and a combined 20 minutes panel session to discuss regulatory challenges from both regulator and pharma perspectives, successes so far and what can be expected in the year of 2020
 
11:00 Overview of MRCT in Asia
James Cai, VP Global Regulatory Affairs, Access & Policy, Amgen, China
 
11:15 Japan
Robert Bruno, Director, Clinical Program Development, Abbvie, Japan
 
11:30 Taiwan
I-Ning Tang, Senior Reviewer, Centre For Drug Evaluation, Taiwan
 
11:45-12:20 Panel: Successes and future strategies to promote cross-country drug development
James Cai, VP Global Regulatory Affairs, Access & Policy, Amgen, China
I- Ning Tang, Senior Reviewer, Centre For Drug Evaluation, Taiwan
Robert Bruno, Director, Clinical Program Development, Abbvie, Japan
 
Mar 211:00
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Low cost, flexible universal adjuvant & delivery system to orally deliver PGT and third party inactivated vaccines for infectious diseases

Vaccines
  •     Traditional vs new generation vaccines to protect against infectious diseases
  •     Building effective vaccines against genetic shifts and the appearance of mutated strains
  •     Moving beyond animal vaccines: How PGT platforms are being developed for human usage
Mar 211:00
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Use of Biocapacitance probes for optimized process control at Large-Scale Manufacturing

Biosimilars
Mar 211:00
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Investor Insights

Biotech Innovation
John Zhu, Partner, Wuxi Hi-Tech Venture Capital Co. Ltd.China
Mar 211:00
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Regenerative medicine by iPSC in Japan

Cell & Gene Therapy
Mar 211:20
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A novel platform technology for vaccine development

Vaccines
A core platform technology for high production of recombinant lipoproteins with built-in immuno-potentiation for novel subunit vaccine development has been established and fully protected by intellectual property. The lipid moiety of recombinant lipoproteins is identical to that of bacterial lipoproteins, which are recognized as a TLR2 agonist with effects on both innate and adaptive immunity. We have successfully demonstrated the feasibility and safety of our core platform technology in meningococcal group B subunit vaccine (MGBvac), dengue subunit vaccine and therapeutic HPV vaccine in model studies. The MGBvac has been approved by Taiwan FDA for Investigational new drug (IND). 
Mar 211:20
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Platform tech development for biosimilar upscaling

Biosimilars
  • Discover strategies to move candidate molecules through development
  • Building consistent, straightforward processes with low variability
  • Exploring the possibility of using single use, high throughput bioreactors in the upscaling process
Mar 211:20
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Biotech Showcase

Biotech Innovation
Mar 211:20
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What’s next after CAR-T in Leukaemia treatment?

Cell & Gene Therapy
CAR-T cell therapy is a combination of cell, gene and immunotherapy and it is finally here, to serve as an alternative cancer treatment. Starting with Leukaemia, CAR-T has been tested on solid tumours, genetic diseases and more. What’s Asia role in the CAR-T I-O field and how do we keep up with global trends?
Mar 211:30
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Biotech Showcase

Biotech Innovation
Mar 211:40
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Artificial cell membrane platform technology for safer, efficient vaccine delivery

Vaccines
Mar 211:40
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Quality measurements in biosimilars upscaling

Biosimilars
  •     What are the deciding factors in ensuring the quality of biosimilars production 
  •     Cost vs quality: what needs to be done to optimise production operation
  •     Inhouse vs outsourcing: Deciding between a more affordable local partner and a costlier but more trustworthy international one
Jaspreet Singh, Vice President of Quality, Intas Pharmaceutical LtdIndia
Mar 211:40
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Mar 211:40
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Innovative tools for risk assessment in drug development

Cell & Gene Therapy
Approximately 30% of drugs have failed in human clinical trials due to adverse reactions despite promising pre-clinical studies, and another 60% fail due to lack of efficacy. There is a need for better and more predictive tools to address this challenge in drug development.  The NIH MPS program is developing alternative approaches for more reliable readouts of toxicity or efficacy. Tissue chips are bioengineered systems utilizing chip technology and microfluidics that mimic tissue cytoarchitecture and functional units of human organs. These microfabricated devices are useful for modelling human diseases, and for studies in precision medicine and environment exposures.
Mar 211:50
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Biotech Showcase- New approach of Leukomycin to severe pneumonia induced with infection such as influenza virus

Biotech Innovation
We are warning of a new pandemic flu, because pandemic influenza induces severe pneumoniae. We have to prepare effective drugs for the severe pneumoniae for the disease. Leucomycin A3 (Josamycin) has been developed for the treatment of infectious diseases. Sugamata et al. showed the anti-inflammatory and anti-viral effects of Leucomycin A3 in the mice infection model. Thus, we started the clinical trials as a pilot study between Philippine and Japan to Leucomycin A3 (Josamycin). Now, we are observing the clinical course of pneumonia and assess the efficacy of Josamycin in severe pneumonia of children.
Mar 212:00
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Mar 212:00
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Biotech Showcase- Fluoro-thalidomide: Biological evaluation of both enantiomers using human myeloma cell line H929 and others

Biotech Innovation
Over the last few years, thalidomide has become one of the most important anti-tumour drugs for the treatment of relapsed-refractory multiple myeloma. However, besides its undesirable teratogenic side effect, its configurational instability critically limits any further therapeutic improvements of this drug. In 1999, we developed fluoro-thalidomide which is a bioisostere of thalidomide, but, in sharp contrast to the latter, it is configurationally stable and readily available in both enantiomeric forms. The biological activity of fluoro-thalidomide however, still remains virtually unstudied, with the exception that fluoro-thalidomide is not teratogenic. Herein, we report the first biological evaluation of fluoro-thalidomide in racemic and in both (R)- and (S)-enantiomerically pure forms against (in vitro) H929 cells of multiple myeloma (MM) using an annexin V assay. We demonstrate that all fluoro-thalidomides inhibited the growth of H929 MM cells without any in-vivo activation. Furthermore, we report that the enantiomeric forms of fluoro-thalidomide display different anti-tumour activities, with the (S)-enantiomer being noticeably more potent. The angiogenesis of fluoro-thalidomides is also investigated and compared to thalidomide. The data obtained in this study paves the way towards novel pharmaceutical research on fluoro-thalidomides.
Mar 212:10
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Biotech showcase

Biotech Innovation
Mar 213:45
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How to Capture Value in a Fast-Paced, Disruptive Industry

Keynotes
Mar 214:05
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Pharma 4.0: How digitisation & disruption are creating a need for agility and entrepreneurship in pharma

Keynotes
Digitisation is changing the way pharma interacts with payers, doctors and patients, leading pharma to seek out different skills and personality traits in employees. The challenge is selecting the right disruptor to foster a forward-thinking organisation, and identifying the suitable digital strategy whilst also complying with local regulations and continuing to invest in core R&D capabilities. Hear from big pharma on how they are moving forward and embracing the digital disruption.
 
Mar 214:25
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AI in pharma: Using digital technology for disease prevention

Keynotes
Mar 215:15
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Good Pharmacovigilance Practice (GVP): What can Asia learn from the EMA?

Regulatory Affairs
The EMA has recently set up a new chapter in its guidelines dedicated to good pharmacovigilance practices.  This is a measurement designed to ensure a robust system for safety monitoring, to protect patients’ interests. What are the similar guidelines in Asia and what can we learn from GVP when running biosimilar trials in Asia? Should GVP be a compulsory practice in Asia?
Mar 215:15
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mRNA based vaccines to prevent infectious diseases

Vaccines
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  •     Cost effective synthesis of mRNA vaccines to prevent infectious diseases
  •     Using naked mRNA and plasmid to induce protective immune response
  •     Delivery of gene encoding vaccine antigens to stimulate infectious disease prevention
  •     Vaccine design in providing rapid response time to emerging pandemics
Mar 215:15
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Mar 215:15
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Case study: What it takes to achieve commercial success for cell & gene therapy products

Cell & Gene Therapy
The uphill path towards commercial success of cell & gene therapy is costly and time extensive. So how do we get there?
Mar 215:25
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Biotech Showcase

Biotech Innovation
Mar 215:35
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Advanced Cell Therapy Regulatory Evaluation in China

Regulatory Affairs
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  •     Defining critical process parameters and critical attributes of emerging therapeutics
  •     Discussing current challenges in manufacturing and logistics of personalised medicine
  •     How can emerging technologies including IoT, AI and more help in potentially overcoming these challenges?
Mar 215:35
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Live saving vaccine initiatives to promote local accessibility and affordability

Vaccines
Mar 215:35
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Cell Therapy for treating Critical Limb Ischemia – an unmet medical need

Cell & Gene Therapy
Critical Limb Ischemia (CLI) is a Peripheral arterial disease (PAD) in the legs, sometimes known as peripheral vascular disease, is frequently caused by atheroma (fatty deposits) in the walls of the arteries, leading to insufficient blood flow to the muscles and other tissues. CLI is a major healthcare issue worldwide and patients with CLI have an increased risk of mortality, myocardial infarction and cerebrovascular disease. The predicted increase in the prevalence of CLI will intensify the demands placed on the healthcare services in India and around the globe. There is therefore a pressing need within the healthcare system to commence an effective therapeutic strategy for treating patients with CLI. Stem Cell therapy likely to address the gaps in the treatment of CLI due to 1) Anti –inflammatory properties 2) Ability to promote neovascularization and 3) promote healing of non-healing ischemic ulcers.
Mar 215:55
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Panel discussion: Using Real World Evidence (RWE) to support the rational use of medicine in Asia

Regulatory Affairs
  • Practicality issues in using RWE in Asia
  • Challenges and opportunities of regulatory innovation for SME pharma companies
  • RWE on emerging therapeutics: Key challenges and opportunities
Mar 215:55
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Keeping the sustainability of high volume, low cost quality vaccines manufacturing in Asia

Vaccines
  • Overview of vaccines manufacturing landscape in APAC
  • Exploring challenges and potential solutions to secure funding for manufacturing technology upgrades
  • Beyond public market: What are the other opportunities which manufacturers can tap on
  • Perspectives sharing: What are we looking for when upgrading existing platforms, and how can we collaborate better with our partners for more cost effective solutions
Mar 215:55
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Mucoadhesive nano-carrier as non-viral vector for ocular gene therapy for the management of glaucoma

Cell & Gene Therapy
Glaucoma is the second leading cause of blindness with 60.5 million patients worldwide in 2010, a figure that is expected to increase to 79.6 million by 2020. Find out how gene therapy helps to treat ocular disorders using mucoadhesive nanocarrier as vector for the treatment.
last published: 14/Feb/18 03:55 GMT